Early Neurological Assessment With Pupillometry in Cardiac Arrest During Resuscitation
NCT ID: NCT05192772
Last Updated: 2022-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
214 participants
OBSERVATIONAL
2022-12-01
2023-12-15
Brief Summary
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Neurological pupil index (NPi) will be used alone and in association with end-tidal CO2.
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Detailed Description
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* T 0: time of enrolling
* T 1: after first cycle of resuscitation (approximatively 2 minutes following guidelines)
* T 2 … Tn: every cycle of CPR (or every 2 minutes if intubated patient) bilateral pupillometry will be collected
* T end: the last pupillometry at ROSC time or death. All pupillometry mesures will be obtained from a technician not trained to interpret NPi index. This to maintain blindness during resuscitation efforts.
Data will be collected in anonymous web-based database passwords protected. For the survivors patients enrolled, data collecting continue in Intensive Care Unit (ICU) as neuroprognostication exams (biomarkers, imaging, neurophysiology). Blind follow up will be obtained from ICU as described in secondary outcome section
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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NPi200
Digital pupillometry performed during cardiopulmonary resuscutation (CPR) every CPR cycle end in case of not intubated patient, or every 2 minutes in case of intubated patient
Eligibility Criteria
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Inclusion Criteria
* unexpected OHCA
* Lombardy region territory
Exclusion Criteria
* Cerebrovascular emergecies at computer tomography (CT) scan after hospital admission
* Peripheral or cortical blindness
* One or both eyes loss
* Iris palsy or known peripheral anisocoria
* No indication for resuscitation
18 Years
ALL
No
Sponsors
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AREU - Agenzia Regionale Emergenza Urgenza
UNKNOWN
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
OTHER
Responsible Party
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Simone Maria Zerbi
Principal Investigator
Principal Investigators
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Simone M Zerbi, MD
Role: PRINCIPAL_INVESTIGATOR
ASST Lariana Ospedale Sant'Anna di Como
Frank A Rasulo, Prof.
Role: STUDY_DIRECTOR
Division of Anesthesiology, Intensive Care & emergency Medicine, Università degli studi di Brescia
Marco Botteri, MD
Role: STUDY_CHAIR
AREU - Agenzia Regionale Emergenza Urgenza
Claudio Sandroni, Prof.
Role: STUDY_CHAIR
Institute of Anesthesiology and Intensive Care Medicine, Università Cattolica del Sacro Cuore, Roma.
Giovanni Chiarini, MD
Role: STUDY_CHAIR
Dip. Anestesia, Rianimazione ed Emergenze II, ASST Spedali Civili di Brescia
Maurizio Raimondi, MD
Role: STUDY_CHAIR
UOC Anestesia e Rianimazione Voghera e Oltrepò, ASST Pavia.
Antonio Bellasi, phD
Role: STUDY_CHAIR
Department of Medicine, Division of Nephrology, EOC, Lugano
Locations
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Agenzia Regionale Emergenza Urgenza - AREU
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Oddo M, Sandroni C, Citerio G, Miroz JP, Horn J, Rundgren M, Cariou A, Payen JF, Storm C, Stammet P, Taccone FS. Quantitative versus standard pupillary light reflex for early prognostication in comatose cardiac arrest patients: an international prospective multicenter double-blinded study. Intensive Care Med. 2018 Dec;44(12):2102-2111. doi: 10.1007/s00134-018-5448-6. Epub 2018 Nov 26.
Riker RR, Sawyer ME, Fischman VG, May T, Lord C, Eldridge A, Seder DB. Neurological Pupil Index and Pupillary Light Reflex by Pupillometry Predict Outcome Early After Cardiac Arrest. Neurocrit Care. 2020 Feb;32(1):152-161. doi: 10.1007/s12028-019-00717-4.
Achamallah N, Fried J, Love R, Matusov Y, Sharma R. Pupillary Light Reflex Is Not Abolished by Epinephrine and Atropine Given During Advanced Cardiac Life Support in Patients Who Achieve Return of Spontaneous Circulation. J Intensive Care Med. 2021 Apr;36(4):459-465. doi: 10.1177/0885066620906802. Epub 2020 Feb 18.
Lee HJ, Shin J, Hong KJ, Jung JH, Lee SJ, Jung E, You KM, Kim TH. A feasibility study for the continuous measurement of pupillary response using the pupillography during CPR in out-of-hospital cardiac arrest patients. Resuscitation. 2019 Feb;135:80-87. doi: 10.1016/j.resuscitation.2018.11.016. Epub 2018 Dec 30.
Zerbi SM, Sandroni C, Botteri M, Bellasi A, Latronico N, Rasulo F. Early Neurological ASsessment with pupillometrY during Cardiac Arrest REsuscitation (EASY-CARE): protocol for an observational multicentre prospective study. BMJ Open. 2022 Dec 20;12(12):e063633. doi: 10.1136/bmjopen-2022-063633.
Other Identifiers
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2494
Identifier Type: -
Identifier Source: org_study_id
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